Composition for amelioration of peri- and post-menopausal symptoms and a process for producing the same

Abstract

The present invention provides a nutraceutical composition, a process for the preparation of the nutraceutical composition useful for amelioration of peri- and post-menopausal symptoms in women. The nutraceutical composition is stable, directly compressible, water soluble, free flowing form having particle size not more than 2.0 μm comprising extract of Trigonella foenum - graecum , at least one bioavailable form of magnesium and vitamin E. The present invention also provides a method of treating ameliorating, treating and/or preventing peri- and post-menopausal discomforts in a subject suffering from peri- or post-menopausal symptoms comprising administering to the subject a therapeutically effective amount of the nutraceutical composition.

The invention claimed is: 
     
       1. A process for producing a nutraceutical composition comprising:
 a. mechanically reducing the seeds of  Trigonella foenum - graecum  to obtain size-reduced particles, 
 b. subjecting the particles of step (a) to solvent extraction to obtain an Extract A, 
 c. separating the particles of step (a) or the extracted particles of step (b) into lighter and heavier fractions based on density using a gravity separator, 
 d. subjecting the lighter fraction obtained from step (c) to solvent extraction and subsequent drying to obtain an Extract B, 
 e. subjecting the heavier fraction obtained from step (c) to extraction with ethanol and water to obtain a micelle, 
 f. separation of the micelle of step (e) into two portions whereby:
 i. the first portion is concentrated under reduced pressure to obtain a liquid phytonutrient rich Extract C having phytoestrogen content in the range of 3 to 8% protodioscin, 
 ii. the second portion is concentrated and purified to obtain a phytonutrient rich Extract D having phytoestrogen content in the range of 10 to 40% protodioscin, 
 
 g. evaporation of the liquid extracts of step (f) to obtain at least water and ethanol, such that the water content is 70 to 90% and the ethanol content is less than 0.5%, and, 
 h. blending vitamin E with the Extract A obtained from step (b) and further mixing into a solution of Extract B containing 1 to 3% of Extract B, the Extract B solution obtained from step (d) followed by addition of the Extract C and Extract D of step (g) with at least one bioavailable form of magnesium to form a nutraceutical composition, 
 wherein the ratio of Extract C to Extract D is in the range of about 4:1 to about 1:4 and the resulting blend is stable and water soluble, having particle size less than 2 μm. 
 
     
     
       2. The process of  claim 1 , wherein the mechanical reduction is by cutting, flaking and/or powdering to a particle size of less than 5 mm. 
     
     
       3. The process of  claim 1 , wherein the extraction of step (b) is solvent extraction with aliphatic alkanes or supercritical fluid extraction and phytochemicals other than oil are not extracted. 
     
     
       4. The process of  claim 1 , wherein the solvent extraction of step (d) is carried out by organic solvents comprising aliphatic alcohols, aliphatic ketones, and mixtures thereof, either alone or in combination with water. 
     
     
       5. The process of  claim 1 , wherein the concentration of steps (f) and (g) is by evaporation at reduced pressure at 600 to 700 atmospheres and a temperature below 50° C. 
     
     
       6. The process of  claim 1 , wherein the purification of step (f)(ii) is by at least one of chromatography, precipitation liquid-liquid extraction, adsorption chromatography or ion-exchange chromatography. 
     
     
       7. The process of  claim 1 , wherein Extract A and Extract B with vitamin E and at least one bioavailable form of magnesium are blended to form a nutraceutical composition.